FDA.reportPublic FDA data

510(k) K221303

Device
Neuspera Nuity System
Applicant
Neuspera Medical, Inc.
510(k) number
K221303
Product code
GZF
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-11
Date received
2022-05-05
Regulation
882.5870
Classification name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alexander Yeh
Address
51 Daggett Dr. San Jose CA US 95134 95134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GZF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243782StimTrial Neuromodulation SystemBioventus, LLC2025-07-16
K243678TalisMann Neuromodulation SystemBioventus, LLC2025-07-03
K232415Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation2024-08-21
K233162Freedom Peripheral Nerve Stimulator (PNS) SystemCuronix2024-06-20
K211965StimRouter Neuromodulation SystemBioness, Inc.2022-02-23
K202781Neuspera Neurostimulation System (NNS)Neuspera Medical, Inc.2021-08-27
K200848Stimulator, Stimulator Kit, External Transmitter, External Transmitter KitMicron Medical Corporation2020-08-14
K200482StimRouter Neuromodulation SystemBioness, Inc.2020-03-27
K190047StimRouter Neuromodulation SystemBioness, Inc.2019-10-31
K191435IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4Nalu Medical, Inc.2019-09-06
K183579Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kitsBoston Scientific Neuromodulation2019-03-29
K171366Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger KitStimwave Technologies Inc., Dba Stimq, LLC2017-08-04
K152178StimQ Peripheral Nerve Stimulator (PNS) SystemStimq, LLC2016-03-11
K142432StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User KitBioness, Inc.2015-02-20
K000852RENEW NEUROSTIMULATION SYSTEMAdvanced Neuromodulation Systems2001-01-19